Determination and pharmacokinetic study of Enasidenib in rat plasma by UPLC-MS/MS

作者：Pang, Ni-hong; Liu, Qian; Lu, Xiang-ran; Yang, Su-fen; Lin, Dong-dong; Hu, Guo-xin^*

来源：Journal of Pharmaceutical and Biomedical Analysis, 2018, 157: 165-170.

DOI：10.1016/j.jpba.2018.04.039

• Enasidenib
• UPLC-MS/MS
• Rat plasma
• Pharmacokinetic study

Enasidenib, an oral product for treating Acute Myeloid Leukemia, has been approved by FDA in Aug, 2017. In this study, we set up an ultra-performance liquid chromatography-mass spectrometry (UPLC-MS/MS) method for measuring Enasidenib and imatinib (internal standard, IS), simultaneously. Enasidenib and imatinib were separated on an ACQUITY UPLC BEH C-18 Column (2.1 mm x 50 mm, 1.7 mu m, 132 angstrom). Mass detection was carried out by electrospray ionization in the position mode, and the multiple reaction monitoring transitions were m/z 474.23 -> 456.17 and m/z 494.30 -> 394.20 for Enasidenib and imatinib, respectively. Linearity (2 - 500 ng-mL(-1), R-2 > 0.999), precision and accuracy (RE < +/- 15%), extraction recovery (>= 96.69%), matrix effect (>= 96.47%) and stability (RE < +/- 10%) were validated which demonstrated the robustness of our method. This rapid, efficient and reliable UPLC-MS/MS method shows specificity and repeatability of Enasidenib in rat plasma and can be used in further pharmacokinetic studies.

• 出版日期2018-8-5
• 单位温州医科大学